Development and Validation of an Instrumented Ankle-foot Orthosis

Not Applicable

Withdrawn

• Conditions: Foot Drop
• Interventions: Device: Instrumented Orthosis

• Registration Number: NCT06115161
• Lead Sponsor: TOPMED

Brief Summary

Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling.

TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-13
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gait Analysis	Instrumented Orthosis	Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5).

Primary Outcome Measures

Name	Time	Method
Gait Temporal parameters	During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session	Gait Temporal parameters measured by the instrumented orthosis and the reference system, in seconds, these include the different phase durations(stride, stance and swing).
Gait Spatial parameters	During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session	Gait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.
Heel strike angle	During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session	Heel strike angle measured by the instrumented orthosis and the reference system
Gait speed	During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session	Gait speed measured by the instrumented orthosis and the reference system, in meters per second.

Trial Locations

Locations (1)

TOPMED; 🇨🇦 Québec, Canada